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Biotech / Medical : Paracelsian Inc (PRLN)

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To: Harold Stone who wrote (3227)9/8/1997 3:42:00 PM
From: Hank   of 4342
 
Harold,

You may be right about needing a government organization like the FDA in the case of something like Hudson Food. However, I think a privatized route for approving drugs would still be beneficial because the FDA often requires data that is not statistically relevent during the approval process. They've even been known to drag their feet when a drug is not considered high priority. Furthermore, I know from talking with people who work in the clinical dept. that much of what the FDA asks for is overkill. This wastes time and money. If the process where streamlined, it would benefit everyone. Also, the FDA often places to much emphasis on specificity. In other words, if a drug candidate does something beneficial for the patient IN ADDITION to it's intended use, the FDA will often claim that it's mechanism of action is non-specific and reject it. Look at all the benefits they've found for aspirin now. Cures headaches, prevents heart attacks, and has even been shown to reduce the risk of certain cancers. Does this make aspirin a "poor" drug candidate in the eyes of the FDA? Were it not for the fact that aspririn is already in commercial use, it would probably never get FDA approval as a new drug today. These are the types of things that need to be eliminated in the current drug approval process. Sure, if private companies ran the show there might be a danger of skewed results in order to keep the clients, drug companies, happy. However, if you make the monitoring agencies libal for false results, then that can be controlled. Over all I don't think there is much danger of drug companies intentionally releasing unsafe drugs to the public. After all, public image has a major impact on their business. Why else do you think they are starting to advertise their drugs more than ever these days? The last thing they want is a public black eye that will affect their bottom line for years to come.

Hank
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